Principal R&D Mechanical Engineer

Edwards Lifesciences is growing and our Principal Mechanical Engineer position is a unique career opportunity that could be your next step towards an exciting role will sit within the Innovalve team as part of Edwards transcatheter mitral and tricuspid therapies (TMTT) product group. Innovalve Bio Medical Ltd. was acquired by Edwards in July 2024 enhancing the companys transcatheter mitral valve replacement (TMVR) technologies to address large unmet structural heart patient needs and support sustainable long-term growth. This role offers an exciting opportunity to be part of the valve R&D team and contribute to the development of a novel device that will revolutionize the treatment of cardiovascular diseases.

How you will make an impact:

As an engineer in the valve R&D team you will provide expertise in design optimization and testing of the Innovalve heart valve implant as part of the product development

• Manage current development and production efforts of current system running through EFS and IDE clinical studies
• Concept Development: Collaborate with cross-functional teams to brainstorm evaluate and find new innovative design concepts
• Design and Development: Design analyse and develop components and processes that meet stringent quality performance and regulatory requirements.
• Problem-Solving: Identify and troubleshoot complex technical issues that arise during development and clinical trials.
• Testing and Validation: Conduct rigorous testing and validation activities including R&D testing Design Verification (DV) testing and clinical trial support.
• Engineering Change Orders (ECOs): Initiate and manage ECOs to implement design changes and improvements.
• Manufacturing Support: Collaborate with manufacturing engineering to ensure seamless transition of designs into production.
• Custom Solutions: Develop tailored solutions for unique design challenges and clinical requirements

Whatyoullneed:

• . inMechanicalengineering
• Minimum of 5 years of experience in medical device design and development.
• Strong understanding of mechanical engineering principles including materials science stress analysis and manufacturing processes.
• Experience designing Nitinol implants
• Experience with FEA and Abaqus software Advantage
• Analytical problem-solving and critical thinking skills.
• Great attention to detail and organizational skills.
• Experience with regulatory requirements
• High verbal communication skills.
• High proficiency in English and Hebrew
• Proficiency in CAD software (SolidWorks or similar).
• Ability to work independently and as part of a cross-functional team
• Willingness to travel abroad 2-3 times a year

About TMTT Business Unit:
Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patients unmet clinical needs. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Every employee is essential to Edwards success and were ready to help you advance along your career path!

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such all Healthcare Interacting positions require COVID-19 vaccination which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired as a condition of employment you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.